Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History

NCT06821685 | Recruiting Phase 1

• 1 other identifier: 2024-LCYJ-PY-50
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.

Conditions

Abortion, Habitual; Infertility Unexplained; Embryo Implantation; Pre-Eclampsia

Keywords

recurrent pregnancy loss; repeated implantation failure; unexplained infertility; decidual natural killer cells

Outcome Measures

Primary Outcomes (1)

• Improvement rate of NK cells

  Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells

  6 months after the first intrauterine infusion therapy

Secondary Outcomes (6)

• Duration of improvement in NK cells

  6 months after the first intrauterine infusion therapy

• Clinical pregnancy

  1 year after completion of NK cells therapy

• Ongoing pregnancy

  1 year after completion of NK cells therapy

• Live birth

  1 year after completion of NK cells therapy

• preeclampsia

  1 year after completion of NK cells therapy

Study Arms (1)

autologous decidual-like NK cells

EXPERIMENTAL

Autologous decidual like NK cells will be isolated and induced in vitro culture from the patients' peripheral blood and perfused into their uterine.

Biological: autologous decidual-like NK cells

Interventions

autologous decidual-like NK cells BIOLOGICAL

intrauterine infusion

autologous decidual-like NK cells

Eligibility Criteria

• Age: 22 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• abnormal uterine NK cell function;
• have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;
• have clear fertility desires;
• normal ovarian function or with frozen embryos;
• edometrium thickness measured by vaginal ultrasound before ovulation or at mid-luteal phase \>= 7mm;
• kg/m\^2 \< Body mass index \< 30kg/m\^2;

You may not qualify if:

• using progesterone receptor modulator;
• chromosomal karyotype abnormalities in one spouse;
• severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;
• uncontrolled autoimmune diseases;
• abnormal blood coagulation function, abnormal liver and kidney function, or other uncontrolled basic diseases (hypertension, diabetes, thyroid disease, etc.) that the researcher access which may affect the progress of the study;
• history of pelvic malignant tumors;
• currently participating in other clinical studies;
• allergic to blood products.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• The University of Science and Technology of China: collaborator

Study Sites (1)

The Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Abortion, Habitual; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced

Study Officials

• Yali Hu

  The Affiliated Drum Tower Hospital of Nanjing University

  PRINCIPAL INVESTIGATOR

• Hui Zhu

  The Affiliated Drum Tower Hospital of Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yali Hu

CONTACT

86-025-83106666; glyyhuyali@163.com

Hui Zhu

CONTACT

86-025-83106666; zhuhui1231@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-06

Locations

CN (1)